Paediatric Rheumatology expert meeting, EMA, London 17.11.2010 - - PowerPoint PPT Presentation

Paediatric Rheumatology expert meeting, EMA, London 17.11.2010

Paul-Ehrlich-Institut

Dirk Mentzer Paul-Ehrlich-Str. 51-59 63225 Langen GERMANY  +49 6103 77-1010  +49 6103 77-1263 pharmakovigilanz1@pei.de http://www.pei.de

Method Frequency of ADR

(-) without relevance (+) possible supportive (++) supportive

> 1/10 - 100 1/100- 1/1000 1/1000 – 1/5000 1/5000 – 1/10000 1/10000 – 1/50000 < 1/50000 Spontaneous reports + ++ ++ ++ ++

• Intensives Monitoring

+ ++ ++ +

• Prescription Event

Monitoring + ++ ++ +

• Case-controll- Studies
• +

++ ++

• PMS Studies

+ ++ +

• Large Data Resources

(+record linkage)

• ++

++ + +

• Clinical trials

++ +

• Methodes for detection of ADR incidence, Meyboom, Drug safety 1997

Present Situation

EU- RMP and Paediatric pharmacovigilance Eudipharm, Paris, 2010, Dirk Mentzer

Background Rate RR to be Detected

(relation of exposed to not exposed is 1:1)

2 5 10 20 1/100 2,319 285 100 40 1/1000 23,518 2,935 1,060 451 1/10,000 235,500 29,433 10,656 4,562 1/100,000 2,355,235 294,411 106,615 45,666 Number of cases needed to detect the difference of an increased risk in comparison to background Incidence.

Detection of risks

Pharmacovigilance